Aspects Associated With Sleep Quality

NCT ID: NCT03766477

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-01-01

Brief Summary

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Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson).

Detailed Description

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This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between 19 and 60 years old will be submitted to polysomnography from January to December 2019. The questionnaires will be applied before the polysomnography, and the APP will be used together with the polysomnography. The data will be tabulated and a descriptive statistical analysis performed. Specific statistical tests will be determined after preliminary analysis of the data (α = 0.05).

Conditions

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Sleep Bruxism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals with sleep bruxism

Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:

* Pittsburgh Sleep Quality Index (IQSP) and Johansson
* Smartphone APP
* Polysomnography

Pittsburgh Sleep Quality Index (IQSP) and Johansson

Intervention Type DIAGNOSTIC_TEST

All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.

Smartphone APP

Intervention Type DIAGNOSTIC_TEST

All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders

Interventions

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Pittsburgh Sleep Quality Index (IQSP) and Johansson

All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.

Intervention Type DIAGNOSTIC_TEST

Smartphone APP

All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.

Intervention Type DIAGNOSTIC_TEST

Polysomnography

All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Noéli Boscato, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noéli Boscato, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

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Noéli Boscato

Pelotas, Rio Grande do Sul, Brazil

Site Status

Noéli Boscato

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FUPelotas2

Identifier Type: -

Identifier Source: org_study_id

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